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ABX464 Maintenance Therapy for Ulcerative Colitis

Not currently recruiting at 713 trial locations

Overseen ByChris Rabbat

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Abivax S.A.

Disqualifiers: Crohn's disease, Colon cancer, others

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABX464, an experimental treatment, to determine its effectiveness for people with ulcerative colitis, a condition causing long-lasting inflammation in the digestive tract. The trial evaluates whether taking ABX464 once daily is safe and effective for those who haven't found success with other treatments like steroids or biologics. Individuals who have tried other ulcerative colitis treatments but still experience symptoms might be suitable for this study. Participants will receive either ABX464 or a placebo to compare results over time. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that certain medications and procedures for ulcerative colitis are prohibited during the study. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that ABX464 is likely to be safe for humans?

Research has shown that ABX464, also known as obefazimod, is generally safe. Studies have found that people with ulcerative colitis, a condition causing inflammation and sores in the colon, who took ABX464 for up to five years did not encounter any new safety issues. This indicates the treatment did not cause unexpected side effects. In an earlier study, patients reported that the drug was well-tolerated, meaning they did not experience significant discomfort or negative reactions. These findings suggest that ABX464 is likely safe for long-term use in managing ulcerative colitis.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatment for ulcerative colitis?

Researchers are excited about ABX464 for ulcerative colitis because it offers a novel approach compared to existing treatments like mesalamine, corticosteroids, and biologics. Unlike these standard therapies, ABX464 works by enhancing the body's natural anti-inflammatory processes through a unique mechanism involving the modulation of RNA splicing, which can potentially reduce inflammation more effectively. Additionally, ABX464's oral administration provides a convenient alternative to injections or infusions, making it easier for patients to adhere to their treatment regimen. This new mechanism and delivery method have generated interest due to their potential to provide better disease management and improved patient quality of life.

What evidence suggests that ABX464 might be an effective treatment for ulcerative colitis?

Research shows that ABX464, also known as obefazimod, may help treat moderate-to-severe ulcerative colitis. Earlier studies found it safe and effective, with many participants experiencing a significant reduction in symptoms after just eight weeks. For example, in recent trials called ABTECT-1 and ABTECT-2, obefazimod achieved its main goal of reducing symptoms. Additionally, more than half of the patients in an earlier study responded positively by the eighth week. This trial will evaluate ABX464 in various dosages, including 25mg and 50mg, for both responder and non-responder subjects at the end of induction, as well as a placebo group. This suggests that ABX464 could be a helpful treatment for those who haven’t had success with other therapies.² ⁵ ⁶ ⁷ ⁸

Who Is on the Research Team?

Severine Vermeire, MD, PhD

Principal Investigator

UZ Leuven, Belgium

Bruce Sands, MD, PhD

Principal Investigator

Mount Sinai Health System Digestive Disease Institute, New York USA

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe ulcerative colitis who didn't get better with standard or advanced treatments. They must have finished a previous ABX464 study and can't be planning pregnancy soon. Participants need valid endoscopy results, agree to use effective contraception, sign consent forms, and commit to the study schedule.

Inclusion Criteria

Subjects must have completed the induction treatment study (ABX464-105 or ABX464-106), and patients' clinical response status must be available.

Subjects should be affiliated to a health insurance policy whenever required by a participating country or state.

I have had an endoscopy with results read by a central reader.

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Exclusion Criteria

I plan to try for a baby in the next year.

Subjects who plan to participate in other investigational studies during the maintenance study.

Subjects who permanently discontinued the study treatment during the induction study (either ABX464-105 or ABX464-106).

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maintenance Treatment

Participants receive ABX464 25 mg or 50 mg or placebo once daily for 44 weeks

44 weeks

Long Term Extension

Participants can continue their allocated treatment for up to 4 years after the maintenance phase

4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End of Study (EOS) visit

What Are the Treatments Tested in This Trial?

Interventions

ABX464

Trial Overview

The trial tests long-term effects of two doses of ABX464 (50mg or 25mg) as daily maintenance therapy compared to a placebo. It's randomized: some get the real drug without knowing if it's high or low dose; others get a fake pill. The treatment lasts 44 weeks followed by an evaluation after another 28 days.

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Placebo Group

Group I: Long Term ExtensionExperimental Treatment1 Intervention

At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study.

Group II: ABX464 50mg - Non responder subjects at the end of inductionExperimental Treatment1 Intervention